Minimal Sedation During Knee Replacement Surgery

This study is looking at whether using an Active Noise Cancelling Headset System with music or a movie can reduce the amount of sedation needed during total knee replacement surgery. This is for patients having a spinal anesthetic (localized anesthesia) instead of full sedation. Researchers will gather feedback from both patients and the surgical team. The study aims to see if this headset system can help lower the amount of Propofol (a sedative) used and improve patient comfort during the procedure. You may be eligible if you are 18 or older, need a primary total knee replacement, and can provide informed consent. The study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design
This is an interventional study planning to enroll 200 participants. It will test the use of an Active Noise Cancelling Headset System during surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured intraoperatively (during surgery).

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NCT07371390

Minimal Sedation During Knee Replacement Surgery

Recruiting
NAAges 18+InterventionalSupportive care
Mayo Clinic
~200 participants
Updated 2026-01-27 on ClinicalTrials.gov
What's tested:Active Noise Cancelling Headset System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Richmond Agitation-Sedation Scale(RASS) Score
Measured over 30 minutes intraoperatively
+2 more outcomes measured
Total Knee Arthroplasty
1 sites across 1 states
Minnesota1
  • Matthew P Abdel, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

Primary Total Knee Arthroplasty
Indicated for Spinal Anesthesia
18+ years old
Participant can independently provide informed consent

Exclusion

Unicompartmental Knee Arthroplasty
Revision Knee Arthroplasty
  • Mean Richmond Agitation-Sedation Scale(RASS) Score30 minutes intraoperatively

    Richmond Agitation-Sedation Scale (RASS) measures the amount of sedation necessary for a patient at different levels of discomfort or agitation during local anesthesia surgeries.

  • Protocol CompletionIntraoperatively

    This will measure the volume of patients that were unable to complete their procedure using spinal anesthesia and due to discomfort or agitation required deep sedation to continue to surgery.

  • Mean Propofol Infusion RateIntraoperatively

    Mean rate of propofol infusion necessary to achieve sedation targets during the procedure. Unit: mcg/kg/min